Back PainNCT00488735
Subacute and Chronic, Non-specific Back and Neck Pain: Cognitive-behavioral Rehabilitation vs. Traditional Primary Care
A study testing Cognitive-behavioral rehabilitation and Traditional primary care in people with Back Pain and Neck Pain, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
BACKGROUND Non-specific back and neck pain (BNP) dominates sick-listing. A program of cognitive-behavioral rehabilitation for subacute and chronic BNP was compared, with 18-month follow-up, with traditional primary care concerning sick-listing and health-care visits. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- What is being tested?
- Cognitive-behavioral rehabilitation and Traditional primary care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 125 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2000to Jul 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Working age up to and including 59 years.
- Sick-listed full-time for BNP for at least 42 days and at most 730 days.
- Able to manage tolerably well to fill in forms.
Who cannot join
- Temporary disability pension or disability pension being paid or in preparation.
- A primary need of action by a hospital specialist.
- Pregnancy and diseases which would probably make rehabilitation impracticable (for example, advanced pulmonary disease).
- Whiplash-associated disorders as a primary obstacle to working.
- Previous rehabilitation at the rehabilitation centre.
- Other multidisciplinary rehabilitation going on or planned.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subacute and Chronic, Non-specific Back and Neck Pain: Cognitive-behavioral Rehabilitation Compared With Traditional Primary Care Concerning Sick-listing and Health-care Visits. A Randomized Controlled Trial, 18-month Follow-up
BACKGROUND
Non-specific back and neck pain (BNP) dominates sick-listing. A program of cognitive-behavioral rehabilitation for subacute and chronic BNP was compared, with 18-month follow-up, with traditional primary care concerning sick-listing and health-care visits.
Read more
METHODS
After stratification to age (44 (years) and younger/45 and older) and subacute/chronic BNP (= full-time sick-listed 43-84/85-730 days respectively), 125 primary-care patients were randomized to a rehabilitation center or continued health-center care. Outcome measures were Return-to-work (=the proportion who regained work ability for at least 30 consecutive days), the proportion with Work ability at different time points, Total sick-listing (expressed in whole days) and the total number of Visits (to physicians, physiotherapists etc.) 1-18 months and corresponding six-month periods. For the analyses were used t-test, z-test, generalized estimating equations and a mixed, linear model.
Read the detailed description
Numbers within parenthesis refers to the place of order in the citation list and within brackets in the link list below.
B A C K G R O U N D
In Sweden, as all over the industrial world, unspecific back and neck pain (BNP) dominates sick-listing (1). Primary care is the appropriate source of treatment of most patients with BNP (2). However, the Swedish traditional primary care lacks the capacity of such an assignment [1]. While the number of practicing physicians is in line with OECD standards, Sweden has, relatively seen, few physicians within primary care. Our overall aim was to compare a program of cognitive-behavioral-rehabilitation at a rehabilitation center for patients with subacute and chronic BNP with traditional primary care. The specific aim of this study was to answer the question: Will the outcome, with an 18-month follow-up, differ concerning sick-listing and number of health-care visits?
M E T H O D S
PARTICIPANTS: One-hundred-and-twenty-five patients were recruited by 42 family doctors at 12 health centers.
INCLUSION AND EXCLUSION CRITERIA: See below
INTERVENTIONS: Cognitive-behavioral rehabilitation: The medical, biomechanical and psychosocial obstacles to working were mapped out. A physiotherapist let the patient into graded activity (3). A behaviorist offered cognitive-behavioral therapy. A health adviser taught applied relaxation (4). A physician prescribed medicine when needed. Then the individual management was replaced by team conferences. A rehabilitation plan was drawn up. The patient gradually returned to work. The end of rehabilitation came when the final aim was achieved or when it was clear that work ability would not be attained. Participation in the rehabilitation group did not exclude the patient from seeking other care also.
Traditional primary care: The hub of Swedish primary care is the health centres. Besides family doctors, their staff consists of, among others, physiotherapists and social workers. In total, the health centers of this study engaged 84 family doctors and served a population of 148 000 individuals, i.e. slightly less than 0.6, as compared with an OECD-average of 0.8, family doctors/1000 population [2]. Participation in the health-center group excluded the patient from turning to the rehabilitation center but not from any other health-care, for example, orthopedist consultation.
DATA COLLECTION: Sick-listing data were provided by the Stockholm County Social Insurance Agency. Data of the treatment at the rehabilitation center were collected from its medical journals. As to the rest, health-care data were obtained from follow-up forms.
OUTCOME MEASURES: See below.
POWER CALCULATION: It originated from a retrospective preliminary study of 172 patients at the rehabilitation centre and from a forecast of the probability of ever regaining work ability for patients with full-time sick-listing for back pain in traditional care (5). The proportion of patients with any degree of work ability at the end of the rehabilitation was 76% and, for the patients with subacute and chronic BNP, 89% and 73% respectively. The average probability of regaining work ability in the case of continued management within traditional care was calculated for each one of the 172 patients according to their period of sick-listing at the start of the rehabilitation and was on average 49% as to be compared with the 76% who really regained work ability. The smallest difference that we wished to demonstrate was 22%. With a significance level of .05 and a power of 80% 154 patients had to be included, and to allow a certain dropout, 170 patients.
PREMATURE STOP OF RECRUITMENT: The recruitment was discontinued in January 2004 at 125 patients. The reason was that in April 2004 a large back-rehabilitation centre started in a neighboring municipality. We presumed that many of the planned future patients of the health-center group would be referred to that centre and get a management that could no longer be defined as traditional primary care.
INCLUSION PROCEDURE: A patient who fulfilled the criteria and agreed to participate was interviewed by telephone by a research assistant. The patients who still qualified saw the assistant at the health center and went through a start form. Then the assistant carried out a 10-test package, including a lift test. The reliability of that test procedure was confirmed in a separate study (6). Then the randomization was made with stratifications to age 44 and younger and 45 and older, and to subacute BNP and chronic BNP, i.e. full-time sick listed 43-84 and 85-730 days respectively. The stratifications were made out from the results of the preliminary study. Randomization envelopes were used. The patients of the rehabilitation group started the program at the centre within one week. The patients of the health-center group continued at their health-centers (= traditional primary care).
FOLLOW-UP: Six, 12 and 18 months after inclusion, the patients were sent follow-up forms.
ANALYSES AND STATISTICS: A p-value<.05 was considered statistically significant. For interval data were used t-test, ordinal data Wilcoxon rank-sum test and proportions z-test. Total sick-listing as well as Visits for the pre- and post-inclusion six-months periods was compared with a mixed-linear model (7).
- Being tested
- Cognitive-behavioral rehabilitation, Traditional primary care
- Keywords
- Randomized controlled trial, Back pain, Neck pain, Rehabilitation, Cognitive-behavioral, Primary care, Sick-listing, Health-care utilization.
- Medical subject headings
- Back Pain, Neck Pain, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral rehabilitationBehavioural
Traditional primary careBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession.
Measured: 18 months.
Secondary outcomes (1)
Work ability (=the proportion with work ability>0). Total sick-listing=the sum of sick-listing of any degree, expressed in whole days. Visits=the total number of consultations to different health-care staff, for example, physicians or physiotherapists.
Measured: Work ability: 18 months. Total sick-listing: 36 months (18 months preceding and after inclusion). Visits: 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startAug 2000
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Investigators
- Lars-Erik Strender, Professor, Study chair, Centre for Family Medicine, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488735
- Sponsor's protocol ID
- KarolinskaI
- Status last verified
- Jun 2007
- First submitted
- 19 Jun 2007
- Last updated
- 7 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Alexanderson K, Norlund A. Swedish Council on Technology Assessment in Health Care (SBU). Chapter 1. Aim, background, key concepts, regulations, and current statistics. Scand J Public Health Suppl. 2004;63:12-30. doi: 10.1080/14034950410021808. No abstract available.
PubMed 15513650Söderström M, Englund L: Treatment of neck and low back pain in primary care. In Neck and back pain. The scientific evidence of causes, diagnosis, and treatment. Edited by Nachemson A, Jonson E. Philadelphia: Lippincott, Williams & Williams; 2000:383-398.
Lindstrom I, Ohlund C, Eek C, Wallin L, Peterson LE, Fordyce WE, Nachemson AL. The effect of graded activity on patients with subacute low back pain: a randomized prospective clinical study with an operant-conditioning behavioral approach. Phys Ther. 1992 Apr;72(4):279-90; discussion 291-3. doi: 10.1093/ptj/72.4.279.
PubMed 1533941Linton SJ: Utility of cognitive-behavioral psychological treatments. In Neck and back pain. The scientific evidence of causes, diagnosis, and treatment. Edited by Nachemson A, Jonson E. Philadelphia: Lippincott, Williams & Williams; 2000:361-381.
Waddell G. Low back pain: a twentieth century health care enigma. Spine (Phila Pa 1976). 1996 Dec 15;21(24):2820-5. doi: 10.1097/00007632-199612150-00002.
PubMed 9112705Brown H, Prescott R: Applied mixed models in medicine. Edinburgh: John Wiley & Sons LTD; 199-259, 2001.
Lindell O, Eriksson L, Strender LE. The reliability of a 10-test package for patients with prolonged back and neck pain: could an examiner without formal medical education be used without loss of quality? A methodological study. BMC Musculoskelet Disord. 2007 Apr 3;8:31. doi: 10.1186/1471-2474-8-31.
PubMed 17407580Lindell O, Johansson SE, Strender LE. Predictors of stable return-to-work in non-acute, non-specific spinal pain: low total prior sick-listing, high self prediction and young age. A two-year prospective cohort study. BMC Fam Pract. 2010 Jul 20;11:53. doi: 10.1186/1471-2296-11-53.
PubMed 20646286Lindell O, Johansson SE, Strender LE. Subacute and chronic, non-specific back and neck pain: cognitive-behavioural rehabilitation versus primary care. A randomized controlled trial. BMC Musculoskelet Disord. 2008 Dec 30;9:172. doi: 10.1186/1471-2474-9-172.
PubMed 19116007
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subacute and Chronic, Non-specific Back and Neck Pain: Cognitive-behavioral Rehabilitation Compared With Traditional Primary Care Concerning Sick-listing and Health-care Visits. A Randomized Controlled Trial, 18-month Follow-up
- ClinicalTrials.gov ID
- NCT00488735
- Acronym / sponsor ID
- KarolinskaI
- Keywords
- Randomized controlled trial, Back pain, Neck pain, Rehabilitation, Cognitive-behavioral, Primary care, Sick-listing, Health-care utilization.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Aug 2000
- Study completion
- Jul 2005 (actual)
- First posted
- 20 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
BACKGROUND
Non-specific back and neck pain (BNP) dominates sick-listing. A program of cognitive-behavioral rehabilitation for subacute and chronic BNP was compared, with 18-month follow-up, with traditional primary care concerning sick-listing and health-care visits.
METHODS
After stratification to age (44 (years) and younger/45 and older) and subacute/chronic BNP (= full-time sick-listed 43-84/85-730 days respectively), 125 primary-care patients were randomized to a rehabilitation center or continued health-center care. Outcome measures were Return-to-work (=the proportion who regained work ability for at least 30 consecutive days), the proportion with Work ability at different time points, Total sick-listing (expressed in whole days) and the total number of Visits (to physicians, physiotherapists etc.) 1-18 months and corresponding six-month periods. For the analyses were used t-test, z-test, generalized estimating equations and a mixed, linear model.
Detailed description
Numbers within parenthesis refers to the place of order in the citation list and within brackets in the link list below.
B A C K G R O U N D
In Sweden, as all over the industrial world, unspecific back and neck pain (BNP) dominates sick-listing (1). Primary care is the appropriate source of treatment of most patients with BNP (2). However, the Swedish traditional primary care lacks the capacity of such an assignment [1]. While the number of practicing physicians is in line with OECD standards, Sweden has, relatively seen, few physicians within primary care. Our overall aim was to compare a program of cognitive-behavioral-rehabilitation at a rehabilitation center for patients with subacute and chronic BNP with traditional primary care. The specific aim of this study was to answer the question: Will the outcome, with an 18-month follow-up, differ concerning sick-listing and number of health-care visits?
M E T H O D S
PARTICIPANTS: One-hundred-and-twenty-five patients were recruited by 42 family doctors at 12 health centers.
INCLUSION AND EXCLUSION CRITERIA: See below
INTERVENTIONS: Cognitive-behavioral rehabilitation: The medical, biomechanical and psychosocial obstacles to working were mapped out. A physiotherapist let the patient into graded activity (3). A behaviorist offered cognitive-behavioral therapy. A health adviser taught applied relaxation (4). A physician prescribed medicine when needed. Then the individual management was replaced by team conferences. A rehabilitation plan was drawn up. The patient gradually returned to work. The end of rehabilitation came when the final aim was achieved or when it was clear that work ability would not be attained. Participation in the rehabilitation group did not exclude the patient from seeking other care also.
Traditional primary care: The hub of Swedish primary care is the health centres. Besides family doctors, their staff consists of, among others, physiotherapists and social workers. In total, the health centers of this study engaged 84 family doctors and served a population of 148 000 individuals, i.e. slightly less than 0.6, as compared with an OECD-average of 0.8, family doctors/1000 population [2]. Participation in the health-center group excluded the patient from turning to the rehabilitation center but not from any other health-care, for example, orthopedist consultation.
DATA COLLECTION: Sick-listing data were provided by the Stockholm County Social Insurance Agency. Data of the treatment at the rehabilitation center were collected from its medical journals. As to the rest, health-care data were obtained from follow-up forms.
OUTCOME MEASURES: See below.
POWER CALCULATION: It originated from a retrospective preliminary study of 172 patients at the rehabilitation centre and from a forecast of the probability of ever regaining work ability for patients with full-time sick-listing for back pain in traditional care (5). The proportion of patients with any degree of work ability at the end of the rehabilitation was 76% and, for the patients with subacute and chronic BNP, 89% and 73% respectively. The average probability of regaining work ability in the case of continued management within traditional care was calculated for each one of the 172 patients according to their period of sick-listing at the start of the rehabilitation and was on average 49% as to be compared with the 76% who really regained work ability. The smallest difference that we wished to demonstrate was 22%. With a significance level of .05 and a power of 80% 154 patients had to be included, and to allow a certain dropout, 170 patients.
PREMATURE STOP OF RECRUITMENT: The recruitment was discontinued in January 2004 at 125 patients. The reason was that in April 2004 a large back-rehabilitation centre started in a neighboring municipality. We presumed that many of the planned future patients of the health-center group would be referred to that centre and get a management that could no longer be defined as traditional primary care.
INCLUSION PROCEDURE: A patient who fulfilled the criteria and agreed to participate was interviewed by telephone by a research assistant. The patients who still qualified saw the assistant at the health center and went through a start form. Then the assistant carried out a 10-test package, including a lift test. The reliability of that test procedure was confirmed in a separate study (6). Then the randomization was made with stratifications to age 44 and younger and 45 and older, and to subacute BNP and chronic BNP, i.e. full-time sick listed 43-84 and 85-730 days respectively. The stratifications were made out from the results of the preliminary study. Randomization envelopes were used. The patients of the rehabilitation group started the program at the centre within one week. The patients of the health-center group continued at their health-centers (= traditional primary care).
FOLLOW-UP: Six, 12 and 18 months after inclusion, the patients were sent follow-up forms.
ANALYSES AND STATISTICS: A p-value<.05 was considered statistically significant. For interval data were used t-test, ordinal data Wilcoxon rank-sum test and proportions z-test. Total sick-listing as well as Visits for the pre- and post-inclusion six-months periods was compared with a mixed-linear model (7).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Working age up to and including 59 years.
- Sick-listed full-time for BNP for at least 42 days and at most 730 days.
- Able to manage tolerably well to fill in forms.
Key exclusion criteria (6 listed)
- Temporary disability pension or disability pension being paid or in preparation.
- A primary need of action by a hospital specialist.
- Pregnancy and diseases which would probably make rehabilitation impracticable (for example, advanced pulmonary disease).
- Whiplash-associated disorders as a primary obstacle to working.
- Previous rehabilitation at the rehabilitation centre.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioral rehabilitation | Behavioural | – |
| Traditional primary care | Behavioural | – |
Primary outcome
Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession.
Time frame: 18 months.
1 secondary outcome
Work ability (=the proportion with work ability>0). Total sick-listing=the sum of sick-listing of any degree, expressed in whole days. Visits=the total number of consultations to different health-care staff, for example, physicians or physiotherapists.
Time frame: Work ability: 18 months. Total sick-listing: 36 months (18 months preceding and after inclusion). Visits: 18 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2010.
- Background: PubMed 15513650Alexanderson K, Norlund A. Swedish Council on Technology Assessment in Health Care (SBU). Chapter 1. Aim, background, key concepts, regulations, and current statistics. Scand J Public Health Suppl. 2004;63:12-30. doi: 10.1080/14034950410021808. No abstract available.
- BackgroundSöderström M, Englund L: Treatment of neck and low back pain in primary care. In Neck and back pain. The scientific evidence of causes, diagnosis, and treatment. Edited by Nachemson A, Jonson E. Philadelphia: Lippincott, Williams & Williams; 2000:383-398.
- Background: PubMed 1533941Lindstrom I, Ohlund C, Eek C, Wallin L, Peterson LE, Fordyce WE, Nachemson AL. The effect of graded activity on patients with subacute low back pain: a randomized prospective clinical study with an operant-conditioning behavioral approach. Phys Ther. 1992 Apr;72(4):279-90; discussion 291-3. doi: 10.1093/ptj/72.4.279.
- BackgroundLinton SJ: Utility of cognitive-behavioral psychological treatments. In Neck and back pain. The scientific evidence of causes, diagnosis, and treatment. Edited by Nachemson A, Jonson E. Philadelphia: Lippincott, Williams & Williams; 2000:361-381.
- Background: PubMed 9112705Waddell G. Low back pain: a twentieth century health care enigma. Spine (Phila Pa 1976). 1996 Dec 15;21(24):2820-5. doi: 10.1097/00007632-199612150-00002.
- BackgroundBrown H, Prescott R: Applied mixed models in medicine. Edinburgh: John Wiley & Sons LTD; 199-259, 2001.
- Results publication: PubMed 17407580Lindell O, Eriksson L, Strender LE. The reliability of a 10-test package for patients with prolonged back and neck pain: could an examiner without formal medical education be used without loss of quality? A methodological study. BMC Musculoskelet Disord. 2007 Apr 3;8:31. doi: 10.1186/1471-2474-8-31.
- Derived from this study: PubMed 20646286Lindell O, Johansson SE, Strender LE. Predictors of stable return-to-work in non-acute, non-specific spinal pain: low total prior sick-listing, high self prediction and young age. A two-year prospective cohort study. BMC Fam Pract. 2010 Jul 20;11:53. doi: 10.1186/1471-2296-11-53.
- Derived from this study: PubMed 19116007Lindell O, Johansson SE, Strender LE. Subacute and chronic, non-specific back and neck pain: cognitive-behavioural rehabilitation versus primary care. A randomized controlled trial. BMC Musculoskelet Disord. 2008 Dec 30;9:172. doi: 10.1186/1471-2474-9-172.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars-Erik Strender, Professor study chair
Centre for Family Medicine, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral rehabilitation and Traditional primary care in people with Back Pain and Neck Pain, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession. (time frame: 18 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00488735, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2010.